Conformal Medical will present data on the first human implants of its unique technology for the prevention of stroke in patients with atrial fibrillation (AFib) at the TCT 2019 meeting September 25, 2019 at 4:30pm.
The study’s principal investigator, William Gray, MD, will present “Second-generation LAA occlusion: Single-size and conforming to a broad range of anatomies.” The Conformal LAAC’s unique foam-based architecture is designed for simpler, more flexible delivery to eliminate the need for general anesthesia.
“We have been quite impressed by the performance of the Conformal Device. Study results support the potential of this device to streamline and simplify the LAA-Closure procedure. It has the real potential to be a game-changer,” said Dr. Gray.
Over five million people in the United States suffer from AFib, putting them at increased risk of stroke. The current standard of care for stroke prevention is chronic use of oral anticoagulants, which can cause uncontrolled bleeding and are not well accepted by patients. The left atrial appendage (LAA) is a pouch off the upper heart chamber where clots associated with stroke in AFib patients form. LAA closure, which eliminates the need for anticoagulation, is emerging as an alternative stroke prevention strategy. The LAA sealing procedure is performed minimally invasively from a small incision in the groin.
Conformal obtained Investigational Device Exemption (IDE) approval for first human use of the Conformal LAA Seal through the FDA’s Early Feasibility Study Program. To date, implants have been performed at four sites throughout the United States.
“We are excited to share the initial results of our trials with the academic community,” says Andy Levine, President and CEO of Conformal Medical. “In the initial stages of this Early Feasibility Study, it appears the Conformal LAAC Implant is performing as it was designed, conforming to a wide range of LAA anatomies with one size.”